| Primary Device ID | 09420012477521 |
| NIH Device Record Key | 8b960fe2-16ee-4fd2-96c0-619305484bc5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | F&P OptiNIV |
| Version Model Number | ONIV117C |
| Catalog Number | ONIV117C |
| Company DUNS | 590153276 |
| Company Name | FISHER & PAYKEL HEALTHCARE LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1810 446 3908 |
| Customer.CareUSA@fphcare.com | |
| Phone | 1810 446 3908 |
| Customer.CareUSA@fphcare.com | |
| Phone | 1810 446 3908 |
| Customer.CareUSA@fphcare.com | |
| Phone | 1810 446 3908 |
| Customer.CareUSA@fphcare.com | |
| Phone | 1810 446 3908 |
| Customer.CareUSA@fphcare.com | |
| Phone | 1810 446 3908 |
| Customer.CareUSA@fphcare.com | |
| Phone | 1810 446 3908 |
| Customer.CareUSA@fphcare.com | |
| Phone | 1810 446 3908 |
| Customer.CareUSA@fphcare.com | |
| Phone | 1810 446 3908 |
| Customer.CareUSA@fphcare.com | |
| Phone | 1810 446 3908 |
| Customer.CareUSA@fphcare.com | |
| Phone | 1810 446 3908 |
| Customer.CareUSA@fphcare.com | |
| Phone | 1810 446 3908 |
| Customer.CareUSA@fphcare.com | |
| Phone | 1810 446 3908 |
| Customer.CareUSA@fphcare.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09420012477491 [Primary] |
| GS1 | 09420012477521 [Package] Contains: 09420012477491 Package: PACK [10 Units] In Commercial Distribution |
| CBK | Ventilator, Continuous, Facility Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-15 |
| Device Publish Date | 2025-12-06 |
| 09420012480491 | F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible |
| 09420012480477 | F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible |
| 09420012480453 | F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible |
| 09420012477521 | F&P OptiNIV ONIV117 Hospital Vented Full Face Mask Compatible with Single-limb Circuits - Size C |
| 09420012477514 | F&P OptiNIV ONIV117 Hospital Vented Full Face Mask Compatible with Single-limb Circuits - Size B |
| 09420012477507 | F&P OptiNIV ONIV117 Hospital Vented Full Face Mask Compatible with Single-limb Circuits - Size A |